Monthly Archives: February 2012

Food and Drug Administration advisers voted against the pleas of consumer advocates on Wednesday to recommend approval of what would be the first new diet drug to hit the US market in 13 years. Called Qnexa, the pill is a combination of two older drugs – one itself a diet pill called phentermine, and an anti-seizure drug that appears to help suppress appetite as part of the combination. Such a new drug is desperately needed, with two-thirds of Americans overweight or obese. Current weight-loss products are limited and have only modest effects. But the field has been littered with failures, as many drugs have often deadly side effects – such as the heart valve damage caused by the once popular combination of phentermine and fenfluramine—Fen-Phen for short. Two other companies have diet drugs up for approval too, and the FDA advisers recommended extra studies on the heart effects of all the drugs. “Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” Sanjay Kaul, a cardiologist at UCLA, said at the FDA panel meeting. Public Citizen … Continue reading →

A U.S. Food and Drug Administration Advisory Committee today recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity . In voting  20 to 2 for approval, the committee said today that Qnexa's weight loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug's side effects, and the FDA rejected it shortly after that. Vivus, the drug's manufacturer, recently submitted additional research. The committee today recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years. The FDA has considered numerous anti-obesity drugs in the past 20 years, but most have failed to meet the agency's standards for safety and effectiveness. But so far, data on Qnexa suggests that the drug is the most effective in helping patients shed up to 10 percent of their body weight. Those changes, along with diet and exercise modifications, could go a long way toward alleviating some of the health … Continue reading →

UNDATED (CBS) -- A Food and Drug Administration panel is holding a new hearing on the weight loss pill Qxena. Research has shown the drug is effective at reducing weight, but health advisers denied approval in 2010 because of its potential side effects including birth defects and increased heart risks. But the earlier decision was based on just one year of clinical data. At today's hearing, the drug maker will show off new safety data from patients who took Qnexa for a second year.  A Food and Drug administration panel is considering whether to recommend a new diet pill called Qnexa which combines the two drugs. A study found obese patients taking Qnexa lost an average 10 percent of their body mass, but the FDA rejected the drug in 2010, concerned about potential side effects including heart problems and birth defects. At Wednesday's hearings, the makers of Qnexa presented encouraging new findings about the drug's safety. More than one out of every three adults in the united states is obese but currently there's only one fda approved drug for weight loss. The FDA has not approved a diet drug since Xenical more than a decade ago. The FDA panel's recommendation is … Continue reading →